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FDA (Device enforcement)Recalled 2022-01-05class ii

Becton Dickinson & Co.: BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066

Is my product affected?

BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066

  • UPC 00382902560661

Check against the official notice below — it lists the full affected range.

What happened

The BD Veritor Plus Analyzer (Catalog Number 256066), a rapid testing device used in medical settings, is subject to a recall due to a potential fire hazard. The risk occurs specifically when an unauthorized AC power adapter other than the one provided by BD is used to power the instrument. The analyzer may overheat and potentially cause a fire under these conditions. Approximately 126,952 to 129,848 units have been distributed worldwide, including throughout the United States and in countries spanning from Armenia to Vietnam.

The recalled analyzers include all unexpired units with expiration dates ranging from December 2021 through August 2024. The source document does not specify a remedy or recommended action for consumers who may have this product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

May have the potential to overheat and/or cause fire, the issue can occur when an unauthorized alternative AC power adapter, and not the one provided by BD is used to power the instrument.

Details from the source

Reason for recall: May have the potential to overheat and/or cause fire, the issue can occur when an unauthorized alternative AC power adapter, and not the one provided by BD is used to power the instrument. Distribution: Worldwide distribution - US Nationwide and the countries of Armenia, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, Fiji, Guatemala, Hong Kong, Honduras, Haiti, Indonesia, India, Jamaica, Cambodia, South Korea, Macao, Mexico, New Zealand, Panama, Peru, Philippines, Singapore, El Salvador, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Vietnam. Quantity: 126,952 Analyzers Updated:129, 848 Analyzers Lot/code info: All unexpired analyzers (Exp. Date 12/2021 - 8/2024) UDI: 00382902560661

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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